88082 Federal Register / Vol. 88, No. 243 / Wednesday, December 20, 2023 / Notices 

38 85 FR 50711. It is possible this would be a onetime expense for sellers to invest in recording 

equipment, as opposed to an annual outlay. But in 

the absence of information as to how sellers manage 

such recordings, the Commission will assume, for 

the purpose of this PRA analysis, that recording 

expense is a recurring annual cost burden. 

39See https://www.globenewswire.com/en/newsrelease/2022/09/05/2509723/0/en/Contact-LensesMarket-Size-Will-Achieve-USD-17-4-Billion-by2030-growing-at-6-9-CAGR-Exclusive-Report-byAcumen-Research-and-Consulting.html. Some 

estimates already put the U.S. contact lens market 

as high as $17 billion, see https://www.vision

monday.com/business/article/us-optical-retailmarket-estimated-at-765-billion-in-the-visioncouncils-first-comprehensive-market-insightsreport/. 

estimates above, the estimated total 

labor cost attributable to the Rule is 

approximately $117,606,597 [($63.99 × 

888,803 optometrist hours = 

$56,874,504) + ($127.62 × 156,848 

ophthalmologist hours = $20,016,942) + 

($19.78 × 1,000,000 prescribers’ office 

clerk hours = $19,780,000) + ($19.78 × 

1,058,400 sellers’ office clerk hours = 

$20,935,152) = $117,606,598]. 

Capital and Other Non-Labor Costs 

Estimated annual non-labor cost 

burden: $591,300. 

Staff believes that the Rule’s 

disclosure and recordkeeping 

requirements described above impose 

negligible capital or other non-labor 

costs, as the affected entities are likely 

to have the necessary supplies and/or 

equipment already (e.g., prescription 

pads, patients’ medical charts, facsimile 

machines and paper, telephones, and 

recordkeeping facilities such as filing 

cabinets or other storage) to perform 

those requirements. The 2020 Rule 

amendments, however, modified the 

Rule to require that sellers who use 

automated verification messages record 

the calls and preserve the recordings for 

three years. The Commission does not 

believe that requiring sellers who use 

automated messages for verification to 

record the calls and preserve them will 

create a substantial burden. The 

requirement will not require additional 

labor time, since the calls will be for the 

same duration as they were previously, 

but may require capital and other nonlabor costs to record the calls and store 

them electronically. Based on comments 

supplied during the Rule modification 

process, the Commission estimates the 

cost to record each verification call at 

five cents apiece.38

Based on survey data, approximately 

36% of contact lens purchases are from 

a source other than the prescriber. 

Assuming that each of the 45 million 

contact lens wearers in the U.S. makes 

on purchase per year, this would mean 

that approximately 16,200,000 contact 

lens purchases are made annually from 

sellers other than the prescribers. And 

since approximately 73% of sales by 

non-prescriber sellers require 

verification, this means that 

approximately 11,826,000 contact lens 

purchases would require verification 

calls, faxes, or emails. The Commission 

does not possess information as to the 

percentage of verifications completed by 

telephone versus fax or email, and thus 

for purposes of this analysis will assume 

that all verifications are performed via 

phone and deliver automated messages 

that are subject to the call-recording 

requirement. Based on the 

aforementioned assumptions, the 

Commission estimates that the 

requirement to record automated 

telephone verification messages will 

cost sellers, in aggregate, $591,300 

(11,826,000 × $.05). 

Total Costs to the Industry (Including 

Labor and Non-Labor Costs) 

Combining the annual labor cost 

burden with the non-labor cost burden, 

the total cost burden of the Rule is 

estimated at $118,197,898 ($117,606,598 

+ $591,300 = $118,197,898). 

This burden is not insubstantial, but 

to put it in perspective, a recent survey 

estimated the value of the U.S. contact 

lens market at approximately $9.6 

billion (not counting examination 

revenue).39 Therefore, the total cost 

burden estimate of $118,197,898, 

imposed by the Rule, represents a cost 

of approximately 1.2% of the overall 

retail revenue generated through the 

sale of contact lenses. 

Your comment—including your name 

and your state—will be placed on the 

public record of this proceeding. 

Because your comment will be made 

public, you are solely responsible for 

making sure that your comment does 

not include any sensitive personal 

information, such as anyone’s Social 

Security number; date of birth; driver’s 

license number or other state 

identification number, or foreign 

country equivalent; passport number; 

financial account number; or credit or 

debit card number. You are also solely 

responsible for making sure that your 

comment does not include any sensitive 

health information, such as medical 

records or other individually 

identifiable health information. In 

addition, your comment should not 

include any ‘‘trade secret or any 

commercial or financial information 

which . . . is privileged or 

confidential’’—as provided by Section 

6(f) of the FTC Act, 15 U.S.C. 46(f), and 

FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— 

including in particular competitively 

sensitive information such as costs, 

sales statistics, inventories, formulas, 

patterns, devices, manufacturing 

processes, or customer names. 

Josephine Liu, 

Assistant General Counsel for Legal Counsel. 

[FR Doc. 2023–27877 Filed 12–19–23; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Notice of Closed Meeting 

Pursuant to 5 U.S.C. 1009(d), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended, and the Determination of 

the Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, CDC, pursuant to Public Law 

92–463. The grant applications and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Disease, 

Disability, and Injury Prevention and 

Control Special Emphasis Panel (SEP)– 

PAR 20–280, Cooperative Research 

Agreements Related to the World Trade 

Center Health Program (U01); RFA–OH– 

24–002, Exploratory/Developmental 

Grants on Lifestyle Medicine Research 

Related to the World Trade Center 

Health Program (R21); RFA–OH–24– 

003, Exploratory/Developmental Grants 

Related to the World Trade Center 

Survivors (R21–No Applications with 

Responders Accepted); and RFA–OH– 

24–004, World Trade Center Health 

Program Mentored Research Scientist 

Career Development Award (K01). 

Dates: March 19–21, 2024. 

Times: 11 a.m.–6 p.m., EDT. 

Place: Video-Assisted Meeting. 

Agenda: To review and evaluate grant 

applications. 

For Further Information Contact: 

Laurel Garrison, M.P.H., Scientific 

Review Officer, Office of Extramural 

Programs, National Institute for 

Occupational Safety and Health, Centers 

for Disease Control and Prevention, 

5555 Ridge Avenue, Cincinnati, Ohio 

45213. Telephone: (513) 533–8324; 

Email: LGarrison@cdc.gov. 

The Director, Office of Strategic 

Business Initiatives, Office of the Chief 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 243 / Wednesday, December 20, 2023 / Notices 88083 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Office of Strategic Business 

Initiatives, Office of the Chief Operating 

Officer, Centers for Disease Control and 

Prevention. 

[FR Doc. 2023–27972 Filed 12–19–23; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–5020] 

Notice to Public of Website Location of 

the Office of the Chief Scientist 

Proposed Guidance Development List 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the website location where 

the Agency will post a list of possible 

topics for future guidance document 

development or revision by the Office of 

the Chief Scientist (OCS) during the 

next year. In addition, FDA has 

established a docket where interested 

persons may provide comments that 

could benefit the OCS guidance program 

and its engagement with stakeholders, 

including comments on the priority of 

topics for guidance. This feedback is 

critical to the OCS guidance program as 

we consider feedback from stakeholders 

along with Agency resources and 

priorities. 

ADDRESSES: You may submit either 

electronic or written comments at any 

time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–N–5020 for ‘‘Notice to Public of 

Website Location of OCS Proposed 

Guidance Development Agenda.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Ross, Office of the Chief 

Scientist, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4332, Silver Spring, 

MD 20993–0002, 301–796–4880 (this is 

not a toll-free number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA welcomes comments on any or 

all of the topics for guidance documents 

on the list as explained in § 10.115(f)(5) 

(21 CFR 10.115(f)(5)). FDA has 

established Docket No. FDA–2023–N– 

5020 where comments on the list, drafts 

of proposed guidance documents on 

those or other topics, suggestions for 

new or different guidances within OCS’s 

purview, and relative priority of listed 

guidance documents may be submitted 

and shared with the public (see 

ADDRESSES). FDA believes this docket is 

a valuable tool for receiving information 

from interested persons. FDA 

anticipates that feedback from interested 

persons will allow OCS to better 

prioritize and more efficiently draft 

guidances to meet the needs of the 

Agency and our stakeholders. 

Consistent with the Good Guidance 

Practices regulation at § 10.115(f)(4), 

OCS would appreciate suggestions that 

OCS revise or withdraw an already 

existing guidance document within 

OCS’s purview. We request that the 

suggestion clearly explain why the 

guidance document should be revised or 

withdrawn and, if applicable, how it 

should be revised. 

II. Website Location of Guidance List 

This notice announces the website 

location of the document that provides 


ddrumheller on DSK120RN23PROD with NOTICES1